Kornimate/medical-research-clean huggingface dataset:
acetaminophen before vaccines for infants study (avis)

Conditions: Fever

Summary: the purpose of this study is to see whether giving acetaminophen (the medicine in tylenol) for routine infant vaccinations is helpful in preventing fever or other symptoms.

post-vaccination fever occurs in up to 40% of infants receiving routinely recommended childhood vaccinations. although serious events are rare, post-vaccination fever causes discomfort for the child, can lead to medical utilization, can rarely result in febrile seizure, and can cause a working parent to miss time from their job to care for a febrile infant who cannot attend day care. the benefits of acetaminophen prophylaxis for infants receiving current vaccinations, in terms of reduction of discomfort for the child, improvement of quality-of-life indicators for the parent, or reduction of medical utilization, have not been measured. this randomized, blinded, placebo-controlled trial will assess the efficacy of prophylaxis with acetaminophen in prevention of fever following routine childhood immunizations.

Eligibility criteria:
inclusion criteria: 1. child is a current group health enrollee. 2. child will be seen at a group health clinic for a well child visit that is expected to include 2 or more vaccines after 6 wks and before 10 months of age. exclusion criteria: 1. if child was born at less than 36 weeks of gestation, the child is not eligible until 4 months of age or older. 2. if the child's birth weight was less than 5.5 pounds (2500 grams), the child is not eligible until 4 months of age or older.

Keywords: acetaminophen vaccination immunization
bosutinib in combination with pemetrexed in patients with selected metastatic solid tumors

Conditions: Carcinoma, Non-Small-Cell Lung; Mesothelioma; Bladder Cancer; Ovarian Cancer; Peritoneal Cancer; Thymoma; Thymus Cancer; Uterine Cervical Cancer

Summary: this study will determine the maximum-tolerated dose (mtd) for oral bosutinib when used in combination with pemetrexed. the mtd is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. this study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.


Eligibility criteria:
inclusion criteria: * pathologically or cytologically proven advanced, metastatic non-squamous non-small cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical cancer. * measurable disease * life expectancy of greater than 3 months. * ability to take folic acid, vitamin b12, and dexamethasone according to protocol. exclusion criteria: - untreated or symptomatic brain metastases.
oral treatment with bibf 1120 together with docetaxel and prednisone in patients with hormone refractory prostate cancer

Conditions: Prostatic Neoplasms

Summary: the primary objective of this study was to determine the safety and maximum tolerated dose (mtd) of bibf 1120 combination therapy with docetaxel and prednisone in patients with hormone refractory prostate cancer. secondary objectives were to characterise the pharmacokinetic profiles of bibf 1120 and docetaxel and possible pharmacokinetic (pk) interactions between bibf 1120 and docetaxel and to obtain preliminary information on anti-tumour activity.


Eligibility criteria:
inclusion criteria: 1. patients with histologically-proven metastatic prostate adenocarcinoma 2. progression after hormonal therapy 3. progressive disease as follows: * increase of psa \> 5 ng/ml on two occasions despite castrate levels of testosterone before screening * and/or progressive measurable disease (recist criteria) * and/or progressive bone metastases (presence of new lesion(s) on a bone scan) 4. life expectancy of at least three months 5. ecog performance status ≤ 2 6. patient written informed consent obtained prior to any trial procedures and that is consistent with ich-gcp (international conference on harmonization - good clinical practice) guidelines. exclusion criteria: 1. prior treatment for hormone refractory prostate cancer (hrpc) including chemotherapy, biologic response modifier therapy, or any investigational drug 2. participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study 3. major injuries and surgeries within the past 4 weeks. planned surgical procedures during the trial 4. brain metastases 5. radiotherapy superior to 30% of the medullar volume 6. other malignancy diagnosed within the past 5 years (other than non-melanomatous skin cancer) 7. gastrointestinal abnormalities that would interfere with intake or absorption of the study drug, such as a requirement for intravenous alimentation, prior surgical procedures affecting absorption, treatment for peptic ulcer disease within the last 6 months, active gastrointestinal bleeding unrelated to cancer (as evidenced by either hematemesis, or melena in the past 3 months and without endoscopic documented resolution), or malabsorption syndromes 8. previous history of stroke, angor pectoris, ischemic cardiomyopathy, cerebral ischemia, arteritis in the past 6 months 9. recent history of hemorrhagic or evolutive thrombotic event (including transient ischemic attacks) in the past 6 months 10. patients who require full-dose anticoagulation or heparinization 11. absolute neutrophil count (anc) \< 1,500/μl, platelet count \< 100,000/μl, or hemoglobin \< 8 mg/dl 12. total bilirubin \> upper limit of normal (uln); alanine amino transferase (alt) and/or aspartate amino transferase (ast) \>1.5 x uln 13. serum creatinine \> 1.5 mg/dl (\> 132 μ mole/l, si unit equivalent) 14. known or suspected active alcohol or drug abuse 15. patients unable to comply with the protocol
comparison of azelaic acid 20 % cream versus hydroquinone 4% cream as an adjuvant to oral tranexamic acid in melasma

Conditions: Melasma

Summary: methodology: fifty female patients presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face) diagnosed by consultant dermatologist on clinical presentation were included in this study. the sample size was calculated by who sample size calculator taking 31% proportion of excellent response with 4% hydroquinone as an adjuvant to oral tranexamic acid as compared to 2.25% proportion of excellent response with 20% azelaic acid, 80% power of test and 5% significance level. after randomization, patients were divided into two groups. group a was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) while group b was managed with topical 20% azelaic acid (daily at night) for six months. clinical evaluation was done initially at the start of therapy and then at 2nd, 4th and 6th month using masi score and patient's response. efficacy was assessed in both groups at the end of therapy after six months.


Eligibility criteria:
inclusion criteria: * female patients * aged 20 to 45 years * presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face) * diagnosed by consultant dermatologist on clinical presentation under wood's light. exclusion criteria: * pregnant patients * women taking contraceptive pills at the time of study or past 12 months * any chronic illness * allergy to any of the agents used in the treatment * those taking any topical and systemic treatment for melasma in the last one month
prospective randomized trial comparing lichtenstein's repair of inguinal hernia with polypropylene mesh versus surgisis

Conditions: Hernia, Inguinal

Summary: to evaluate the safety and efficacy of the lichtenstein's hernioplasty using the surgisis es soft tissue graft, as a mesh, and to compare it with the traditional lichtenstein procedure performed with polypropylene mesh.

inclusion and exclusion criteria inclusion criteria: * male, adult patients * asa i-iii patients * non-complicated primary inguinal hernia (classification according to gilbert i-ii-iii-iv-v-vi, modified. according to rutkow and robbins) performed in non-emergency setting and repaired with a lichtenstein's hernioplasty using polypropylene or surgisis mesh * informed consent exclusion criteria * recurrent hernias * any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted) * hypersensitivity to any drug in study * patients with an intra-operative findings of different pathology will be excluded from the study outcomes: general objectives of the study will be: 1. to determine the safety of the lichtenstein's hernioplasty with surgisis es by noting any complications observed intraoperatively and postoperatively 2. to determine the efficacy of the lichtenstein's hernioplasty with surgisis es in comparison with the traditional method with polypropylene mesh by noting the grade of postoperative pain, discomfort, quality of life, the rate of wound infection and other complications, and the recurrence rate. the specific objectives of the study will be: 1. to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (vas), simple verbal scale (svs) and parenteral/oral analgesic consumption in the two groups. 2. to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (vas) and simple verbal scale (svs). 3. to measure the postoperative health general status and quality of life with the short form 36 (sf-36) questionnaire. 4. to rate the wound infection risk. 5. to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period. 6. to measure the recurrence rate.

Eligibility criteria:
inclusion criteria: * male, adult patients * asa i-iii patients * non-complicated primary inguinal hernia (classification according to gilbert i-ii-iii-iv-v-vi, modified. according to rutkow and robbins) performed in non-emergency setting and repaired with a lichtenstein's hernioplasty using polypropylene or surgisis mesh * informed consent exclusion criteria: * recurrent hernias * any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted) * hypersensitivity to any drug in study * patients with an intra-operative findings of different pathology will be excluded from the study

Keywords: hernioplasty polypropylene extracellular matrix xenograft
the mentalplus® for assessment and rehabilitation of cognitive function after remission of the symptoms of covid-19

Conditions: Cognitive Impairment; Covid19; Cognitive Dysfunction; Depression, Anxiety; Quality of Life

Summary: this study evaluates and rehabilitates the cognitive functions of attention, memory, visual perception, language, and executive by the mentalplus® digital game of covid-19 surviving patients after remission of symptoms.

subjects who contracted covid-19 and present remission of symptoms will be studied, with different age groups, illiterate or literate, of both genders and with different socio-demographic characteristics. the volunteers will be submitted to the application of mentalplus® to assess cognitive functions and sf-8® to assess quality of life.

Eligibility criteria:
inclusion criteria: * patients affected by covid-19 with or without comorbidity for cardiovascular diseases, diabetes mellitus, hypertension, cancer, asthma between the ages of 8 and 88 years of both sexes and illiterate or literate. exclusion criteria: * disability for the instrument's use: limitation for the mobility of the upper limbs, presence of significant mental retardation that compromises the understanding of the instructions for the use of mentalplus®, significant lowering of visual acuity.
position-induced opening of the intervertebral foramen is efficient to treat an acute lumbosacral radiculopathy caused by disc herniation

Conditions: Radiculopathy Lumbar; Disk Herniated Lumbar; Low Back Pain

Summary: efficiency of the conservative mechanical lumbosacral nerve root decompression, as an adjunct to pharmacological treatment, in the case of acute lumbosacral radiculopathy.

non-invasive position-induced opening of the intervertebral foramen in sidelying position, as an adjunct to pharmacological treatment, was used in the case of acute lumbosacral radiculopathy. 20 examinees were split into two groups, 10 in the experimental and 10 in the control group. experimental group was given positional opening of the intervert. foramen, together with pharmacological treatment - steroid antiinflammatory drug - dexamethasone, nonsteroid antiinflammatory drugs and pain killers while control group was given just the same pharmacological treatment and recommended rest. measured dependent variables were: 1. visual analogue pain scale (vas) for the low back and radiculopathy, separately 2. straight leg raise in supine position - nerve mobility test 3. euroqol questionnaire - general health condition questionnaire 4. oswestry questionnaire - activities of daily living (adl) specific questionnaire for low back pain and lumbosacral radiculopathies inclusive criteria were: age between 20 - 60, lumbar disc herniation recognized by the mri, lumbosacral radiculopathy with symptoms such as radicular pain, sensation dysfunctions or motor dysfunctions, recognized by electromyography (emg) diagnostics. exclusive criteria: age more than 60, degenerative lumbar stenosis, spondylolisthesis, vertebra fractures, tumours. conclusion: physiotherapy with a positional, mechanical decompression of the compressed lumbosacral nerve root, as an adjunct to pharmacological treatment, is proved to be efficient with the lumbosacral radiculopathy. it is recommended to be applied since the first day of a patient admittance in the hospital if there is a position that can reduce the pain.

Eligibility criteria:
inclusion criteria: 1. age between 20 - 60 2. lumbar disc herniation proved by mri 3. lumbosacral radiculopathy with symptoms of radicular pain, sensation dysfunction, and motor dysfunction proved by emg diagnostics. exclusion criteria: 1. age older than 60 2. degenerative lumbar stenosis 3. spondylolisthesis 4. vertebrae fractures 5. tumor metastasis
evaluation of the importance of risk-factor adjustment for assessing the relationship between voriconazole utilization and the development of non-melanoma skin cancer among lung and heart/lung transplant patients, 2002-2009g

Conditions: Non-Melanoma Skin Carcinoma

Summary: the primary objective of the study is to assess the relationship (both crude and adjusted) between voriconazole utilization and the development of non-melanoma skin cancer among adult patients who received a lung or heart/lung transplant and were continuously enrolled in a large u.s. commercial health plan.

n/a. all patients aged 18 or older who received a lung or heart/lung transplant from january 1, 2002 through december 31, 2009 in the marketscan database were sampled.

Eligibility criteria:
inclusion criteria: * patients aged 18 or older who received a lung or heart/lung transplant from january 1, 2002 through december 31, 2009 in the marketscan database will be initially included in the study. exclusion criteria: * patients who are younger than 18 years of age and who are not enrolled for at least 180 days before and 180 days after the date of transplant will be excluded.

Keywords: voriconazole non-melanoma skin cancer confounding statistical adjustment risk adjustment lung transplant heart/lung transplant immunosuppression
differential adaptation of renal function in intense physical exercise

Conditions: Acute Kidney Injury

Summary: in recent years there has been a significant increase in the number of participants in high intensity and duration sports events. this type of physical exercise has been reported to lead to an apparently transitory deterioration in kidney function. the injury mechanisms involved in this process have not been fully studied, but several have been proposed as potential causes, such as tissue ischemia, disruption of the permeability of the glomerular basement membrane, damage to the ultra-structure of skeletal muscle, structural involvement of the renal parenchyma, exercise-associated hyperthermia or insufficient hydration during exercise. urinary biomarkers, which are a more precise tool than serum creatinine when it comes to detecting subclinical kidney damage, may be key to elucidate the characteristics of exercise-related kidney injury. the aim of this study is to carry out an integrative analysis of the development of exercise-associated subclinical acute kidney injury.


Eligibility criteria:
inclusion criteria: * age ≥18 years. * able to understand the objectives of the study and to provide informed consent. * body mass index between 18.5 and 24.9 kg / m2 * active sportsman/woman (defined as previous experience with the planned tests and performing vigorous-intensity aerobic activity at least three times per week). exclusion criteria: * history of chronic kidney disease, hypertension, uncontrolled diabetes (defined as fasting glucose levels ≥200 mg/dl or hba1c ≥9%), peripheral vascular disease, heart disease, neurological disease or thyroid disease. * use of nsaids in the 72h prior to the test. * consumption of statins or anabolic steroids. * some kind of major physical injury in the four months prior to the tests.

Keywords: acute kidney injury
the impact of medical clowning on pain and stress level in pediatric patients undergoing hernia repair surgery laugh study.

Conditions: Umbilical Hernia; Inguinal Hernia

Summary: the purpose of our study to quantitatively examine the stress levels prior to surgery and the use of analgesics post surgery in both children and their parents following a preoperative intervention with a medical clown compared to children that were not exposed to this intervention.


Eligibility criteria:
inclusion criteria: * ages 4-10 years old * undergoing elective umbilical or inguinal hernia repair surgery * asa physical status = 1 exclusion criteria: * none

Keywords: medical clown
a study to investigate how the body handles multiple doses of pf-0243873 and to investigate the effect of pf-02413873 on sex hormone levels in healthy young women

Conditions: Endometriosis

Summary: the study will investigate how well multiple doses of pf-02413873 are tolerated by healthy young women, how the body handles multiple doses of pf-02413873 and which effect pf-02413873 has on sex hormones in healthy young women


Eligibility criteria:
inclusion criteria: * healthy women of childbearing potential with a regular menstrual cycle exclusion criteria: * evidence or history of any major disease * pregnant or nursing women * requirement for chronic medication
efficacy and safety of houtou jianweiling tablet in the treatment of chronic non-atrophic gastritis

Conditions: Gastritis

Summary: to study the efficacy \& safety of houtou jianweiling tablet through the non-inferiority clinical trial of houtou jianweiling tablet with omeprazole enteric-coated tablet in patients with chronic non-atrophic gastritis.

this is a randomized, double-blind, placebo-controlled, non-inferiority clinical trial on the efficacy and safety of houtou jianweiling tablet in the treatment of chronic non-atrophic gastritis.

Eligibility criteria:
inclusion criteria: * (1) comply with the diagnostic criteria for chronic non-atrophic gastritis. * (2) age between 18 to 65 years. * (3) voluntarily participate the clinical trials and sign informed consent. exclusion criteria: * (1) subjects with history of gastric surgery. * (2) patients with complicated and special types of gastritis, peptic ulcer, hemorrhage, cholecystitis, cholelithiasis, dysplasia of gastric mucosa or pathological diagnosis of suspected malignant change. * (3) patients with atrophy and/or intestinal metaplasia through pathological examination showed;. * (4) severe primary diseases associated with cardiovascular, cerebrovascular, lung, liver, kidney and hematopoietic system (above grade ii of cardiac function; cr value above the upper limit of normal value), or serious diseases affecting their survival, such as cancer or aids; * (5) patients who have used chinese and western medicine to treat chronic non-atrophic gastritis in the last two weeks; * (6) subjects with psychiatric disorders or a history of alcohol/drug abuse; * (7) pregnant women, woman who are preparing for pregnancy, lactating women; * (8) patients who are allergic constitution or allergic to known ingredients of test drugs; * (9) those who have participated in or are participating in other drug clinical trials in the past 3 months; * (10) the syndrome differentiation is not clear or there are too many and complicated syndromes for the subjects; * (11) subjects that researchers do not consider appropriate to participate in clinical trials. * (12) patients with poor compliance are not allowed to participate in this trial. * those who meet one or more of the above exclusion criteria cannot be included in the clinical trial.
comparison of synthetic mammography versus full-field digital mammography in image interpretation and performance metrics

Conditions: Breast Carcinoma

Summary: this study compares synthetic mammography to full-field digital mammography in image interpretation and performance metrics. digital breast tomosynthesis (dbt) has previously been found to be superior in performance to standard digital mammography in both screening and diagnostic settings for the early detection and improved diagnosis of breast cancers. dbt in combination with full-field digital mammography (ffdm) reduces recall rates and increases cancer detection rates relative to ffdm alone. synthetic mammography is a 2-dimensional reconstructed image, using the dataset derived from the dbt acquisition, without requiring additional radiation dose. collecting information from patients' medical records may help doctors analyze the characteristics, utility, and impact of synthetic mammography to compared to ffdm.

primary objective: i. to analyze the characteristics, utility, and impact of synthetic mammography (sm), as compared with full-field digital mammography (ffdm). outline: patients' medical records and past imaging examinations are reviewed.

Eligibility criteria:
inclusion criteria: * female * age 18 or older * consecutive cases in breast imaging center exclusion criteria: * cases demonstrate administrative or technical errors (e.g. missing views, labeling inconsistent with report, etc.)
a study to observe the safety and tolerability of paliperidone palmitate (invega sustenna) in korean schizophrenic patients

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the safety and tolerability of paliperidone palmitate over a 9-week period for participants with schizophrenia in korea.

this is an open-label (all people know the identity of the intervention), multi-center, prospective (look forward using observations collected following participant enrollment), non-comparative, non-randomized (the study medication is not assigned by chance), study. safety and efficacy of paliperidone palmitate will be observed in korean schizophrenic participants for 25 weeks. approximately 3000 participants will be observed in this study and the study duration will be 25 weeks. safety evaluations will include assessment of adverse events, concomitant medications, physical examination, and psychiatric history.

Eligibility criteria:
inclusion criteria: * participants diagnosed with schizophrenia * participants prescribed with paliperidone palmitate for acute or maintenance treatment exclusion criteria: * participants who received paliperidone palmitate for other than the approved indication

Keywords: schizophrenia paliperidone palmitate invega sustenna korea